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WASHINGTON — TUESDAY, September 25, 2012 (MedPage Today) — The FDA has announced the creation of an internal task force to review policies related to antibacterial drug development, which has been in steady decline since the 1980s and almost completely stopped of late.

Leaders in the antibiotic development community praised the new FDA task force, which was announced in a press release Monday, saying it could help the agency revise development guidelines that have hamstrung product development.

"This task force will help come up with ideas for moving the FDA forward," Bob Guidos, vice president of public policy at the Infectious Diseases Society of America, told MedPage Today.

That new thinking, he said, ultimately will lead to more favorable requirements for clinical trials. "Without changes, there would be no antibiotics."

For example, the FDA currently requires a clinical trial proving the drug is not inferior to a placebo or comparator drug. But the FDA's requirements for demonstrating clinical improvement are so strict that antibiotic developers have a difficult time either meeting those standards or finding enough patients to make a smaller clinical difference statistically meaningful, Guidos said.

In addition, unlike with cancer drugs, no surrogate endpoints currently exist that would work in testing antibiotics for efficacy. "Traditional studies that FDA requires have become more difficult for companies to achieve," he added.

Also, while approval requirements have tightened, antibiotic resistance has become more of a concern, the FDA noted in its release.

"More than 70 percent of the bacteria that cause hospital-associated infections are resistant to at least one type of antibacterial drug most commonly used to treat these infections," the agency said, noting that, for example, in 2002 about 2 million Americans developed hospital-associated infections resulting in around 99,000 deaths.

The task force is comprised of 19 FDA scientists and clinicians. The FDA news release identified four priorities for the task force:

Explore novel approaches to antibiotic development such as broader use of clinical pharmacology data, innovative clinical trial designs and new measures of efficacy

Identify unmet medical needs and reasons for the lack of a pipeline to meet such needs

Evaluate existing FDA guidance and determine if revision is needed

Use existing collaborators to explore development

About 12 years ago, when the agency last redrafted many of its development guidelines to better define non-inferiority, it largely based its requirements for designing clinical trials on studies from the 1930s and 1940s — the time of a boom in antibiotic development, according to antibiotic development consultant David Shlaes, MD, PhD.

The FDA finally realized basing modern trial designs on 80-year-old endpoints won't work because no company will use them, he said.

For example, the FDA requires patients in trials for hospital-acquired bacterial pneumonia not have had an antibiotic for the past 28 days, Shlaes said. But those patients are some of the sickest in the hospital and would have surely received some antibiotic in the last month, disqualifying any potential patient for a trial.

The task force announcement follows the passage of the Generating Antibiotic Incentives Now (GAIN) Act, which was signed into law in July. The law, sponsored by Rep. Phil Gingery, MD (R-Ga.), extends an additional 5 years of market exclusivity to antibiotics that treat a serious or life-threatening disease. It also mandates the FDA review antibiotic-related guidance to spur development.

"The real hope is that it's going to create a much more significant milestone than the GAIN Act because this looks at the scope of the problem," Guidos said.

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